Clinical trials: Profound Hearing Loss
Severe Sudden Sensorineural Hearing Loss
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period
- Trial name
- AUDIBLE-S (NCT03603314)
- Testing
- SENS-401
- Where
- 26 sites in Bulgaria, Canada and 8 more
- Volunteers
- 115 people
- Sponsor
- Sensorion
Cochlear Implant, Severe-Profound Hearing Loss
Bimodal, CROS and Severe Profound Hearing Loss Study
The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids.
- Conditions
- Cochlear Implant, Severe-Profound Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- NCT04222296
- Testing
- Fitting strategy of cohlear implant of hearing aid
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Deafness
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing…
- Trial name
- HearCog (NCT04495660)
- Testing
- Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation, Task A not B
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Toulouse
Hearing Loss
Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Cochlear implants require programming on an individual basis to provide appropriate levels of electrical stimulation. This program, or "map", is placed in the speech processor of the cochlear implant.
- Trial name
- NCT00331539
- Testing
- Cochlear Implant
- Where
- Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bnai Zion Medical Center
Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Designing a Trial of Bilateral Cochlear Implantation in Adults
In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even…
- Trial name
- FOUNDATION (NCT03287700)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Nottingham University Hospitals NHS Trust
Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Conditions
- Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- DETECT (NCT06424262)
- Testing
- CI622D, CI622
- Where
- 11 sites in Australia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Cochlear
Severe to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear
Wide Diameter Bone Anchored Implant Study
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant.
- Conditions
- Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss
- Trial name
- NCT01671176
- Testing
- Wide diameter bone anchored implant
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
Sensorineural Hearing Loss, Bilateral, Cochlear Implants
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
- Trial name
- TICI (NCT04571333)
- Testing
- Mi2000 Totally Implantable Cochlear Implant
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral, AUNB1
Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.
- Conditions
- Sensorineural Hearing Loss, Bilateral, AUNB1, DFNB1A, Congenital Deafness
- Trial name
- Otoconex (NCT05402813)
- Testing
- Pure Tone Audiometry Assessment, Quality of Life Questionnaires
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Sensorion
Severe to Profound Prelingual Hearing Loss
Language Development in Children With Cochlear Implants and Speech-language Therapy Interventions
Cochlear implantation is currently offered to children with severe to profound prelingual hearing loss for whom hearing aids alone are insufficient to provide access to oral language (HAS, 2009).
- Trial name
- ICORTHO (NCT07447427)
- Testing
- Speech-language therapy (observed standard care)
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Frequency Compression, Severe-profound Hearing Impairment
Use of Frequency Compression in Severe-profound Hearing Loss Adults
The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses.
- Trial name
- FC (NCT04623112)
- Testing
- Hearing aid feature: Frequency Compression
- Volunteers
- 27 people
- Sponsor
- University College, London
Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss
Cochlear Implantation in Cases of Single-Sided Deafness
The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an…
- Conditions
- Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss, Single-Sided Deafness (SSD)
- Trial name
- CI in SSD (NCT02203305)
- Testing
- Cochlear Implant, Control Group
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of North Carolina, Chapel Hill
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
Profound Bilateral Hearing Loss
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol.
- Trial name
- ROBIICCA (NCT05696171)
- Testing
- Cochlear implant manual insertion, Cochlear implant robotized insertion
- Where
- 14 sites in France
- Volunteers
- 550 people
- Sponsor
- Nantes University Hospital
Profound Hearing Loss, Cochlear Implants
The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (= C-Subjective).
- Trial name
- eSRT (NCT06051006)
- Testing
- ESR and ECAP measurements, Device setting, Speech audiometry
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sudden Hearing Loss
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
- Trial name
- NCT07814677
- Testing
- intracochlear injection of triamcinolone acetonide through the round window membrane, intratympanic dexamethasone injection through the tympanic membrane
- Where
- China
- Volunteers
- 56 people
- Sponsor
- Eye & ENT Hospital of Fudan University
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
- Trial name
- NCT01616576
- Testing
- Control first, then Experimental, Experimental first, then Control
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Advanced Bionics